Trade Names:Droxia- Capsules 200 mg- Capsules 300 mg- Capsules 400 mg
Trade Names:Hydrea- Capsules 500 mgApo-Hydroxyurea (Canada)Gen-Hydroxyurea (Canada)
Inhibits DNA synthesis, interferes with conversion of ribonucleotides to deoxyribonucleotides, and may inhibit incorporation of thymidine into DNA.
Hydroxyurea is rapidly absorbed. T max is 1 to 4 h.
Hydroxyurea distributes rapidly and widely in the body, and concentrates in leukocytes and erythrocytes. Vd approximates total body water.
Up to 60% of an oral dose undergoes metabolic conversion through pathways not fully characterized (eg, degradation by urease found in intestinal bacteria, saturable hepatic metabolism).
Excretion is likely a linear first-order process. In patients with sickle cell anemia, the mean urinary recovery is about 40%.
Because renal excretion is a pathway of elimination for hydroxyurea, consider dosage reduction in patients with renal impairment. Closely monitor hematologic parameters.Hepatic Function Impairment
No data are available supporting specific guidelines for dosage adjustment in patients with hepatic insufficiency. Closely monitor hematologic parameters.
Reduce frequency of painful crises and reduce need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises.Hydrea
Tumor response has been demonstrated in melanoma; recurrent metastatic or inoperable carcinoma of the ovary; resistant chronic myelocytic leukemia (CML); in combination with irradiation therapy for local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.
Cervical carcinoma; polycythemia vera; essential thrombocytosis; HIV; thrombocythemia; psoriasis; in combination with radiation therapy as a radiation sensitizer in brain tumors, cervical cancer, and head and neck cancer.
Hypersensitivity to any component of the product. Marked bone marrow depression (ie, leukopenia [less than 2,500 WBC] or thrombocytopenia [less than 100,000]) or severe anemia ( Hydrea ).
Base dosage on patient's actual or ideal weight, whichever is less.Concomitant Irradiation Therapy (Carcinoma of Head and Neck)Adults
80 mg/kg as a single dose every third day, beginning at least 7 days before initiation of irradiation and continued during radiotherapy as well as indefinitely afterwards provided the patient is adequately observed and exhibits no unusual or severe reactions.Renal InsufficiencyAdults
A single-dose study suggests that in sickle cell anemia the initial dose should be reduced by 50% to a dose of 7.5 mg/kg daily.Resistant CMLAdults
PO Continuous therapy of 20 to 30 mg/kg as a single daily dose.Sickle Cell AnemiaAdults Initial dose
15 mg/kg/day as a single dose. If blood cell counts are at acceptable levels, dosage may be increased by 5 mg/kg/day every 12 wk until max tolerated dose (highest dose not producing toxic blood cell counts over 24 consecutive wk), or 35 mg/kg/day, is reached. Dose is not increased if blood cell counts are between acceptable and toxic levels. If blood cell counts are considered toxic, discontinue hydroxyurea until hematologic recovery, then resume therapy after reducing dosage by 2.5 mg/kg/day from dose associated with hematologic toxicity. Then, titrate dose up or down every 12 wk in 2.5 mg/kg/day increments until patient is at a stable dose that does not result in hematologic toxicity for 24 wk. Any dose that produces hematologic toxicity twice should not be given again.Solid TumorsAdults Hydrea Intermittent therapy
80 mg/kg (2,000 to 3,000 mg/m 2 ) as a single dose every third day.Continuous therapy
PO 20 to 30 mg/kg as a single daily dose. Hold the dose if WBC decreases to less than 2,500/mm 3 or platelet count is less than 100,000/mm 3 .
Store capsules at controlled room temperature (59° to 86°F) in a tightly closed container.
Hepatotoxicity, fatal hepatic failure, and severe neurotoxicity reported with concomitant use in HIV-positive patients.Didanosine, stavudine
Pancreatitis and hepatotoxicity have been reported.Myelosuppressive agents, radiation therapy
Risk of bone marrow depression or other adverse events may be increased.Uricosuric agents (eg, probenecid)
Hydroxyurea may increase serum uric acid levels.
None well documented.
Asthenia; convulsions; disorientation; dizziness; drowsiness (following large doses); hallucination; headache; malaise; severe peripheral neuropathy.
Alopecia; atrophy of the skin and nails; black nail pigmentation; cutaneous vasculitic toxicities including gangrene and vasculitic ulcerations; dermatomyositis-like skin changes; facial erythema; hair loss; hyperpigmentation; maculopapular rash; peripheral erythema; scaling; skin cancer; skin rash; skin ulceration; violet papules.
Anorexia; constipation; diarrhea; nausea; pancreatitis (fatal and nonfatal); stomatitis; vomiting.
Abnormal bromsulphalein (BSP) retention; dysuria; temporary impairment of renal tubular function with elevated BUN, creatinine, and uric acid.
Bleeding; low reticulocytes levels; low platelet levels; neutropenia.
Elevated hepatic enzymes; hepatotoxicity (fatal and nonfatal).
Acute pulmonary reactions consisting of diffuse pulmonary infiltrates, dyspnea, and fever.
Fever; chills; edema; parvovirus B-19 infection.
Treatment of patients with hydroxyurea capsules may be complicated by severe, sometimes life-threatening adverse reactions. Hydroxyurea is mutagenic, clastogenic, and genotoxic. Secondary leukemias have been reported in patients receiving long-term hydroxyurea for myeloproliferative disorders.
Closely monitor hematologic parameters in patients with renal or hepatic insufficiency. Monitor patients' blood cell counts every 2 wk. Determine hematologic status, kidney function, and hepatic function prior to and repeatedly during treatment.
Category D .
Excreted in breast milk.
Safety and efficacy not established.
May be more sensitive to the effects of hydroxyurea and may require a lower dosage regimen.
May temporarily impair renal tubular function accompanied by elevated serum uric acid, BUN, and creatinine levels. Use with caution; consider reducing the dose.
Because hydroxyurea is cytotoxic and myelosuppressive, do not administer if bone marrow function is markedly depressed.
Hydroxyurea is presumed to be a human carcinogen.
Patients who have received prior irradiation therapy may have an exacerbation of postirradiation erythema.
Self-limiting megaloblastic erythropoiesis is often seen early in hydroxyurea therapy.
Acute mucocutaneous toxicity, edema of palms and soles followed by scales of hands and feet, severe generalized hyperpigmentation of the skin, soreness, stomatitis, violet erythema.
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